QP Certification Not applicable to study Clause Samples
This clause establishes that Qualified Person (QP) certification requirements do not apply to the study in question. In practice, this means that the study's investigational products or processes are exempt from the standard QP review and certification typically mandated for clinical trials or pharmaceutical manufacturing in certain jurisdictions. By clarifying this exemption, the clause ensures that parties understand QP oversight is not required, thereby streamlining regulatory compliance and avoiding unnecessary procedural delays.
QP Certification Not applicable to study. 16.1 The QP should be guided in fulfilling their duties by the Code of Practice for QPs in the Pharmaceutical Industry. NA
16.2 No product will be dispatched without prior approval by the CUSTOMER.
16.3 The sponsor is responsible for ensuring that all products, which they intend to release for distribution to clinical sites, have been certified by a QP.
16.4 The CUSTOMER is responsible for ensuring that the API is manufactured according to GMP. Where product is undergoing QP certification by CATALENT, the CUSTOMER must provide information requested by the Catalent QP as evidence of GMP compliance.
16.5 CUSTOMER is responsible for ensuring the required Ethics Committee and Regulatory approvals are in place before requesting shipment to a clinical site.
16.6 Responsibility for QP certification will be defined for each study in the project documentation.
16.7 Where CUSTOMER is responsible Tor QP certification of the finished product, the sponsor will provide a final release certificate for each batch of product, signed by an eligible QP, as evidence of QP certification prior to CATALENT Internal release and distribution of product to site by CATALENT.
16.8 For manufacture and packaging which takes place within the EU, unless otherwise specified in project documentation, a CATALENT QP will provide a certificate confirming that operations carried out at a CATALENT facility have been conducted in compliance with EU Good Manufacturing Practice (GMP).
16.9 If specified in Project documentation, a CATALENT QP will confirm that the product complies with the specification noted in the Clinical Trial Application (CTA) and other documents provided by the CUSTOMER. The CATALENT QP will require the CUSTOMER to provide that part of the CTA and other specifications pertinent to the activities carried out by Catalent. The CTA must be in the English language and the CUSTOMER must confirm that the content of any CTA submitted in another language is identical.
16.10 If the final certification is the responsibility of the CATALENT QP, CATALENT is named as the “Authorized site for release of the finished product or Investigational Medicinal Product (IMP) in the Community” as recorded in the CTA. To discharge these duties, the CATALENT QP will require CUSTOMER to provide the following: ● Clinical Trial Application and Investigational Medicinal Product Dossier (CTA and IMPD) or equivalent for each country (provided in the English language and confirmation that applications in othe...